Clinical trial · Interventional
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?
Reducing Re-excisions After Breast Conserving Surgery: A Randomized Controlled Trial Comparing the MarginProbe Device in Addition to Standard Operating Procedure Versus Standard Operating Procedure Alone in Preventing Re-excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The new device we are looking at is called the MarginProbe. It is a disposable probe which measures the margins of tissue removed to check they are clear of cancer cells, during breast conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue if necessary, during the same operation if any involved margins are identified. This minimises the need for further repeat operations. Previous studies carried out elsewhere in the world (USA and Israel) have identified that the probe reduces re-excision rate but there has never been a study in the UK. The trial involves randomly allocating patients once they are in theatre, to either the MarginProbe procedure after breast conserving surgery and radiology has been completed, or not.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MarginProbe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Device Arm
- description
- Randomized for MarginProbe device to be used during surgical procedure
- interventionNames
- Device: MarginProbe
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Randomized for surgical procedure to happen as per standard care
Primary outcomes (1)
- measure
- To determine if intraoperative margin assessment after excision of a cancer reduces second operations (reexcision or mastectomy), compared to standard surgical practice by 9 months after primary surgery.
- timeFrame
- 9 months post surgery
- description
- To determine if the use of the MarginProbe device, after surgical tumour excision and tissue specimen radiography of a breast cancer reduces rates of further surgical re-excision operations (re-excision or mastectomy), when compared to control/standard practice(whereby the wound is closed after radiography showing clear margins).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria; * Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically. * Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b). * Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent. Exclusion Criteria; * Unsuitable for BCS on basis of tumour size (\<1.5cm or \>4cm) or stage. * Radiotherapy contraindicated. * No histopathological evidence of DCIS or invasive lobular cancer. * Neoadjuvant chemotherapy.
References
Publications (0)
Data not yet available